Study Evaluating Sirolimus in Kidney Transplant Recipients

Wyeth

Status and phase: Completed; Phase 3

Conditions: Graft vs Host Disease; Kidney Transplantation

Treatments: Drug: cyclosporine; Drug: daclizumab; Drug: sirolimus; Drug: mycophenolate mofetil; Drug: corticosteroids

Study type: Interventional

Funder types: Industry

Identifiers

NCT00195273

0468H-101466

Details and patient eligibility

About

The purpose of this study is to compare the kidney function in patients who have received a transplanted kidney and were treated with the combination of sirolimus, daclizumab, mycophenolate and corticosteroids versus transplanted patients treated with cyclosporine, mycophenolate and corticosteroids.

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Kidney transplantation
• Donor must be at least 60 years old.

Exclusion criteria

• Current systemic infection
• Unstable angina or treatment for serious arrhythmia.
• Cancer within the previous 5 years.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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61 participants in 2 patient groups

1

Experimental group

Description:

Sirolimus + Daclizumab + Mycophenolate + Corticosteroids

Treatment:

Drug: mycophenolate mofetil

Drug: daclizumab

Drug: sirolimus

Drug: corticosteroids

2

Active Comparator group

Description:

Cyclosporine + Mycophenolate + Corticosteroids

Treatment:

Drug: mycophenolate mofetil

Drug: corticosteroids

Drug: cyclosporine